A randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, safety, tolerability and efficacy of omiganan BID in patients with mild to moderate atopic dermatitis

Phase 2

Completed

• Conditions: atopic dermatitis; 10040790; Eczema

• Registration Number: NL-OMON42963
• Lead Sponsor: Cutanea Life Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
2. AD diagnosis confirmed;
3. Symptoms present for at least 1 year;
4. EASI between 7.1 - 50.0, inclusive at screening;
5. 2-20% body surface area (BSA) affected at screening;
6. Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg;
7. Able to participate and willing to give written informed consent and to comply with the study restrictions;
8. Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.

Exclusion Criteria

1. Any current and / or recurrent clinical significant skin condition other than AD;
2. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
3. Ongoing use of prohibited atopic dermatitis treatments. Washout periods prior to baseline (first dose of the study drug) are as follows:
a. Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic immunosuppressants: 4 weeks
b. Phototherapy: 3 weeks
c. Biologics: 5 half-lives of the drug
d. Topical calcineurin-inhibitors: 10 days;
4. Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area;
5. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
6. Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients;
7. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
8. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening;

Study & Design

• Study Type: Interventional
• Study Design: Not specified